Impact of Postoperative Adjuvant Chemotherapy in Patients With Hepatocellular Carcinoma After Liver Transplantation
Overview[ - collapse ][ - ]
Purpose | The study is designed to investigate the effect of postoperative adjuvant chemotherapy in prevention of tumor recurrence and metastasis for hepatocellular carcinoma after liver transplantation. |
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Condition | Liver Transplantation Hepatocellular Carcinoma Tumor Recurrence and Metastasis Survival Adjuvant Chemotherapy |
Intervention | Drug: gemcitabine and oxaliplatin Drug: doxorubicin, 5-Fu and cisplatin |
Phase | N/A |
Sponsor | Shanghai Jiao Tong University School of Medicine |
Responsible Party | Shanghai Jiao Tong University School of Medicine |
ClinicalTrials.gov Identifier | NCT01125020 |
First Received | May 17, 2010 |
Last Updated | May 17, 2010 |
Last verified | May 2010 |
Tracking Information[ + expand ][ + ]
First Received Date | May 17, 2010 |
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Last Updated Date | May 17, 2010 |
Start Date | December 2008 |
Estimated Primary Completion Date | December 2010 |
Current Primary Outcome Measures | tumor recurrence and metastasis [Time Frame: within the first year after liver transplantation] [Designated as safety issue: No]Examination of tumor recurrence include serum levels of alpha-fetoprotein(AFP), chest radiography, abdominal ultrasonography, chest or abdominal computed tomography (CT), magnetic resonance imaging (MRI) and bone scintigraphy |
Current Secondary Outcome Measures | Postoperative survival [Time Frame: within the first year after liver transplantation] [Designated as safety issue: Yes]Postoperative survival include rates of disease-free survival (DFS), overall survival(OS), tumor recurrence and death. |
Descriptive Information[ + expand ][ + ]
Brief Title | Impact of Postoperative Adjuvant Chemotherapy in Patients With Hepatocellular Carcinoma After Liver Transplantation |
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Official Title | Not Provided |
Brief Summary | The study is designed to investigate the effect of postoperative adjuvant chemotherapy in prevention of tumor recurrence and metastasis for hepatocellular carcinoma after liver transplantation. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | N/A |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition |
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Intervention | Drug: gemcitabine and oxaliplatin Gemcitabine 1000mg/m2 (days l, 8) and oxaliplatin 130mg/m2 (day l) delivered as an intravenous infusion, given every 28days and repeat six times. Drug: doxorubicin, 5-Fu and cisplatin Doxorubicin 20mg/m2 (days 1, 3), 5-Fu 300mg/m2 (days 1-5) and cisplatin 20mg/m2 (days 1-3) delivered as an intravenous infusion, given every 28days and repeat six times. |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 150 |
Estimated Completion Date | December 2010 |
Estimated Primary Completion Date | May 2010 |
Eligibility Criteria | Inclusion Criteria: - All liver transplantation patients with hepatocellular carcinoma between Dec 2008 and May 2010 are potentially eligible for enrollment. Exclusion Criteria: - Age less than 18 years - Treatment with other postoperative adjuvant chemotherapy - Survival is less than 3 months after liver transplantation - Inability to provide written informed consent prior to study entry |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Jun-Yi Wu, MM 0086-021-63240090 wjy8541@126.com |
Location Countries | China |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01125020 |
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Other Study ID Numbers | 2008BAI60B03 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | Shanghai Jiao Tong University School of Medicine |
Study Sponsor | Shanghai Jiao Tong University School of Medicine |
Collaborators | Shanghai Changzheng Hospital |
Investigators | Study Chair: Zhi-Hai Peng, MD Shanghai First People's Hospital |
Verification Date | May 2010 |
Locations[ + expand ][ + ]
Shanghai First People's Hospital | Shanghai, Shanghai, China, 200080 Contact: Zhi-Hai Peng, MD | 0086-021-632400903132 | pengpzh@hotmail.comPrincipal Investigator: Jun-Wei Fan, MD Recruiting |
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